Saturday, August 29, 2015

Class-Wide DPP-4 Diabetes Med Effect: Joint Pain -- FDA Warns, On Friday

I'll note this almost solely to complete the record, here -- since we try to run down all material items related to Merck.

As we've previously indicated, in fairly short order, the SGLT-2 class will be supplanting the DPP-4 class as the oral diabetes med of first choice (beyond metformin -- a Merck drug, but now long generic). This FDA revision will likely hasten that coming switch-over, at least for prescribers with patients complaining of recurrent joint pains, along with their diabetes. Not good news, here in the US -- for Kenilworth -- but only a minor headwind near term, overall, for the behemoth that is Merck's annual revenue tide, rolling in. Here's the FDA press alert -- and the list of covered products:

. . . .The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.

Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. . . . [Affected DPP-4 class products]:

Januvia (sitagliptin), Janumet (sitagliptin and metformin), Janumet XR (sitagliptin and metformin extended release), Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Tradjenta (linagliptin), Glyxambi (linagliptin and empagliflozin Jentadueto (linagliptin and metformin), Nesina (alogliptin), Kazano (alogliptin and metformin), Oseni (alogliptin and pioglitazone). . . .

So it goes. . . . Meanwhile, our eyes will be on the night skies for a few evenings now. . . smilingly so, immortal and beloved. . . .

Friday, August 28, 2015

O/T: The Dream -- Set On Wings -- 52 Years On. . .

This turns out to be a Friday afternoon for. . . reflections. And reflect we shall -- on the eve of my long-gone father's own birthday. For today is the day that Dr. King spoke -- at the March on Washington. Today he set his version of the dream. . . on wing. So do take a moment and express gratitude, for all this moment did to advance our nation -- to this very day.

Below is -- of course -- from his letter inside the Birmingham Jail. . . and the YouTube below that, is "the dream" proper.

. . . .My friends, I must say to you. . . . it is an historical fact that privileged groups seldom give up their privileges voluntarily. Individuals may see the moral light and voluntarily give up their unjust posture. . . .

Frankly, I have yet to engage in a direct action campaign that was "well timed" in the view of those who have not suffered unduly from the disease of segregation. For years now I have heard the word "Wait!" It rings in the ear of every Negro with piercing familiarity. This "Wait" has almost always meant "Never." We must come to see, with one of our distinguished jurists, that "justice too long delayed is justice denied."

We have waited for more than 340 years for our constitutional and God given rights. The nations of Asia and Africa are moving with jetlike speed toward gaining political independence, but we still creep at horse and buggy pace toward gaining a cup of coffee at a lunch counter. Perhaps it is easy for those who have never felt the stinging darts of segregation to say, "Wait." But when you have seen vicious mobs lynch your mothers and fathers at will and drown your sisters and brothers at whim; when you have seen hate filled policemen curse, kick and even kill your black brothers and sisters; when you see the vast majority of your twenty million Negro brothers smothering in an airtight cage of poverty in the midst of an affluent society; when you suddenly find your tongue twisted and your speech stammering as you seek to explain to your six year old daughter why she can't go to the public amusement park that has just been advertised on television, and see tears welling up in her eyes when she is told that Funtown is closed to colored children. . . .

[W]hen you take a cross county drive and find it necessary to sleep night after night in the uncomfortable corners of your automobile because no motel will accept you; when you are humiliated day in and day out by nagging signs reading "white" and "colored". . . .

[It is also the 60th passing of the murder of young Emmett Till.] Travel light, but travel well, Dad (and Ter -- 30 years on) -- you both had to leave our party far too soon.

Wednesday, August 26, 2015

Of The Persistence Of Communicable Diseases: Three New Ebola Cases, In Guinea Last Week

The good news tonight is that Sierra Leone is approaching the 42 day marker again -- on being Ebola free. However, Guinea has seen new cases -- one of them a cabbie, in an urban area -- so we might expect several more cases, unless all his contacts are found, and vaccinated in an immediate ring fashion. And that is exactly what the Guinea health authorities are now undertaking. [The last re-emergence in Guinea was June 2015, as we had previously reported.]

Again, it is the single course (as opposed to a "prime plus booster" approach -- needed in the GSK candidate), and rVSV-ZEBOV's extremely robust near-term efficacy, that have handed the Merck/NewLink vaccine the wheel, in Africa. Here's the operative bit -- from the online CIRAP center, on the campus of the University of Minnesota:

. . . .With three new cases, Guinea was the only country in West Africa's outbreak region to report Ebola infections last week, and responders are on high alert because all of the confirmed case-patients, one of them a taxi driver, pose a high risk of transmission.

The World Health Organization (WHO) said in its weekly snapshot of the outbreak that Sierra Leone has gone two weeks without a new case and that the outbreak region's weekly total has remained at three for four weeks in a row. . . .

Now, sleep well, all you young buckaroos. . . and do say your prayers -- that this latest Ebola ring-outbreak is snuffed out soon. G'night!

New! With Now Daily Propecia® MDL Documents Updates: The Good Doctor Must Appear -- At High Noon, On September 10, 2015, Sez US Magistrate Judge

The emminently capable Magistrate Judge Pohorelsky, sitting in Brooklyn's federal District courthouse has ruled that the doctor will be given one additionnal week to prepare, but that both she -- and her Weill-Cornell Medical Center lawyer -- WILL in fact have to appear personally, to answer his questions about the state of the play, on these supposed 16 to 40 boxes of study documents. Now that is. . . fascinating.

So -- if anyone were to wander by (and bring a picture ID, to be granted admission to the gallery) they could sit in that day, in Brooklyn. It could turn out to be a pretty darn interesting show cause hearing, given the interplay between what has been reported to be the doctor's earlier position -- per her lawyer -- and what we all understand the federal rules governing national clinical trials for FDA approval of new drug candidates might have required of her. Do stay tuned, but I have no plans to be in New York that day, at this point. Here is the full text of today's order -- just entered, below:

. . . .Order on Motion for Discovery: the Hearing on the Order to Show Cause is adjourned to September 10, 2015 at 12:00 noon. Dr. Julianne Imperato-McGinley and her counsel are both required to attend in person. Ordered by Magistrate Judge Viktor V. Pohorelsky on 8/25/2015. . . .

The delay from September 2 -- to September 10 -- was designed to accommodate the doctor's availabilty -- to appear in person. Pop the popcorn folks! [And, in answer to Mr. E (below), there was no status hearing scheduled for today, given yesterdaty's developments -- it was superceded/deleted.] Onward.

Tuesday, August 25, 2015

August 25, 2015 Propecia® MDL Document Discovery Update -- Small Delivery Of Documents Made; And An Assertion That Many More Are. . . "Missing"

Again, I must emphasize that we should not infer too terribly much from the plaintiffs' lawyers' claims that the vast bulk of the historical Propecia® study documents have gone "missing". But the surprising news here (to my eye) is that only some 630 or so pages were turned over by the University hospital, as of yesterday afternoon.

And so, with that said, I do think the plaintiffs make a generally very solid point -- when they ask where the doctor's study files -- as PI of the clinical trials (some of which were submitted to, or filed with federal agencies) -- now reside. [There is a passing and rather vague reference, to the Dominican Republic here, as well -- and it may well turn out that some records need to be culled from storage, on the island.] As I've indicated before, the federal rules contemplate that those documents should remain under the control, directly or indirectly, of the principal investigator -- precisely in the event that questions like those raised in the present mass tort litigation arise. The rules contemplate having a repository (under the direct supervision of a particular person -- the doctor) for exactly this sort of eventuality. Here is the Response filed today (a six page PDF file), by the plaintiffs' lawyers -- and a bit of it:

. . . .On August 24, 2015, in response to the Second Subpoena, Weill Cornell Medical College produced a mere 631 pages of documents, constituting less than half a box [of a purported 40 boxes]. . . .

The documents appear to contain nothing from Dr. Imperato-McGinley’s days researching in the Dominican Republic, nothing about her discovery, and just a handful of documents related to Merck. The paltry production by Weill Cornell Medical College emphasizes, as opposed to eliminates, the continued need for a “show cause” hearing with regard to the issue of Dr. Imperato-McGinley’s documents, and where these highly relevant and probative documents went. . . .

Though Ms. Orwel repeatedly affirms that Dr. Imperato-McGinley has no documents in her possession, custody, or control, these statements must be disregarded under Second Circuit precedent, as Ms. Orwel does not claim to have personal knowledge, or even any “knowledge,” regarding the factual question of what documents Dr. Imperato-McGinley has or had in her possession, custody, or control. . . .

Dr. Imperato-McGinley should appear in Court and explain to this Court why she has produced in effect absolutely nothing in response to the Subpoena served upon her. This Court should direct Dr. Imperato-McGinley to appear before this Court and show cause why she should not have to produce all responsive documents, to provide an explanation as to what if any documents were destroyed and when they were destroyed, advise what prompted counsel to initially believe there were between sixteen and forty boxes, and what those boxes contain, and find Dr. Imperato-McGinley in contempt of Court if she continues to refuse to comply with the Subpoena. . . .

The conclusion of the just filed Response renews the plaintiffs' request that the doctor be required to appear personally, and explain the whereabouts of the clinical trial documents. I remain skeptical that the Court is ready to order that appearance. I do think the Court will ask the counsel for Weill-Cornell to make an accounting of what was in the 40 boxes -- and which parts of it might not be discoverable. So -- do stay tuned for September 2, 2015. Onward -- and be excellent to one another!

Monday, August 24, 2015

BioPharma Dive: On An Apparently Cardio-Protective Side-Effect Of Lilly's Jardiance® -- Longer Term Effect On Merck's Januvia® Sales

While the markets gyrate rather wildly on concerns about emerging market growth -- or the lack thereof, more precisely -- we will take a moment to look forward, into 2016-2017, and predict that (if this preliminary study result holds up, upon peer review) Jardiance® may eat into Merck's more than $5 billion franchise, here. The Boehringer Ingelheim/Lilly drug is an SGLT2 inhibitor, and Merck's only current bet in this space is in a venture shared with Pfizer. That venture effort is not likely to reach market before 2018, in my estimation.

All of which is to say I think Merck would be quite vulnerable to product switching -- away from Januvia® -- should Jardiance turn out to provide a reduced cardio-vascular risk to most diabetes patients. [As we've reported before, repeatedly, Merck's presently-available study data shows only that there is no increased cardiovascular risk with Januvia.] Speaking broadly, and oversimplifying, here -- longer term cardio-vascular events are generally the proximate cause of disability/death for people with advanced diabetes. So it stands to reason that a drug able to mitigate that risk would be welcomed with open arms, by prescribing doctors. Here is BioPharma Dive's quite cogent take on it all:

. . . .Merck's Januvia is often used as treatment for diabetes when metformin is not enough to control blood glucose. Diabetes is treated in a stepwise fashion, generally starting with metformin and adding on various classes of drugs over time. Given the new data published about Jardiance, Jardiance could become the go-to drug after metformin.

As mentioned in BioPharma Dive's coverage last week, the positive news about Jardiance, which is an SGLT-2 inhibitor could bode well for the entire class, including Johnson & Johnsons Invokana and Bristol-Myers Squibb's Farxiga. . . .

And so (from a larger, macro- perspective) -- in the longer run, the emerging markets will be a net positive for the solid counter cyclicals, like pharma and biotech. There may -- as ever -- be bumps along the way (as today is no doubt proving). . . Enjoy, one and all!

Friday, August 21, 2015

Former President Carter Receiving Merck's Keytruda® -- Investigational/Experimental Use; Off Label -- For Brain Tumors

I half-wondered if Mr. Carter would receive the BMS (Opdivo®) or Merck (Keytruda®) breakthrough therapy, when I read of his interview, last evening, in the Gray Lady. Now we know -- he will. And we may well see outstanding results, even for a patient in his 90s. It is indeed a heady time for science.

I'll have more later -- on a train, at the moment. . . This could be a nice institutional marketing coup -- for Kenilworth, if he sees any progression free survival, of statistical significance.

Okay -- do go read it:

. . . [The former President] immediately began treatment with a drug that’s new to the market. Carter is receiving pembrolizumab, better known by its brand name, Keytruda, according to the Washington Post. . . .

Of course, since the use is experimental -- and prescribed directly by his oncologists -- presumably without any input from Merck, proper, there is no off-label regulatory concern, for Merck. More soon... Onward -- and we wish Mr. Carter the very best here.

Thursday, August 20, 2015

I'd Not Bet On Intarcia's Implantable Device Besting Merck's Januvia® -- Before 2019, At Least

To be sure, the just reported results look promising: using a matchstick sized implantable pump to release diabetes meds like Byetta® continuously, and silently.

The new tech has done well against Merck's sitagliptin franchise -- in early efficacy tests. The problem (as I see it) with the tech is that an oral treatment is likely going to be vastly preferred by patients (compared to any implantation), and compounding that, the SGLT2 class of diabetes meds are due to come online, and may well leapfrog this device, altogether. Merck has a bet in the SGLT2 class, via a venture with Pfizer, of course. Some of those competitors may come online in late 2016. [Intarcia is partnered with French megalith Servier, on this device.]

It is not so much that Inarcia will best Merck, today, as it is that other diabetes drugs are showing a cardiovascular risk benefit not seen in Januvia®, that is moving Merck stock today. In any event, a bit, from Bloomberg Biz, then:

. . . .Intarcia’s pump is implanted under the skin for up to a year and continuously delivers a diabetes drug known as a GLP-1 receptor agonist. The pump reduced a measure of blood glucose by 1.5 percentage points, compared with 0.8 percentage point for Januvia, in a yearlong study of 535 patients, the company said Tuesday in a statement. The device also led to an average weight loss of 4 kilograms (9 pounds), compared with a loss of 1.3 kilograms in the patients taking Januvia.

Intarcia, a closely held company backed by venture-capital firms including New Enterprise Associates Inc. and Venrock, is seeking to challenge the crowded field of type 2 diabetes treatments with its device, called ITCA 650. . . .

And so -- the 4 per cent sacking of Merck's NYSE price seems. . . a little overwrought, to my experienced eye. Onward!

I've Been Generally Impressed By USW Local 10-86's Merck Strategies, But This I Don't Entirely Follow. . .

Longer term readers will recall that I have generally been a strong supporter of the plight of the unionized workforce at West Point -- some 1,800 strong (down from over 2,000 in 2010).

This week, however,'s blogs have been covering an emerging email debate between Local 10-86's leadership, and Merck's CEO. What seems to be lost in the dust up here is that it apparently broke into the public over what union leadership has characterized as Mr. Frazier's granting all non-unionized workers at Merck an "extra" day off, in appreciation of their efforts, this year -- on the Friday before Labor Day. [In the last contract negotiations -- in 2013 -- so-called floating holidays were a rather contentious issue with Local 10-86, and Merck management.]

In point of fact, Mr. Frazier granted the non-unionized workers a day off -- one that the collective bargaining agreement for Local 10-86 already made a "floating holiday" -- for all the union workers. That's in addition to Monday, Labor Day. Here's FiercePharma, restating what I think SHOULD be the more salient bits of the discussion:
. . . .Frazier in return, explains that collective bargaining agreements make it hard sometimes to offer the same perks to all employees.

The CEO assured Bangert that union workers are appreciated and added, "Merck goes to great lengths to protect the safety and well-being of our employees." He assured him that manufacturing management and HR would "work with local site leaders to address your concerns directly". . . .

From my perspective, all Mr. Frazier is guilty of. . . is granting all employees an equal right -- to that enjoyed by the union employees -- a floating day off on the Friday before Labor Day weekend.

Now, it is true that the remainder of the layoffs mentioned in the Form 10-Q are still coming -- some 2,600 of them -- and mostly to shop floor workers, as opposed to office dwellers -- who've already been cut by around 40,000 over the past five years, world-wide (inclusive of legacy Schering-Plough's cuts).

That should be the focus of the discussions -- not whether there was any disrespect of the unionized workers (by the CEO), in granting all others the same paid holiday the union presently enjoys. That -- and the "compulsory overtime" at West Point (with its attendant potential safety issues) -- those are serious, and public-debate worthy, topics for the union's public letter writing campaign, from my perspective.

Tuesday, August 18, 2015

UPDATED Propecia® MDL Documents Spat: The Weill-Cornell Med Center In-House Lawyer Weighs In, This Afternoon

Well, it once again seems unlikely that there will be any high drama show-down in Brooklyn's federal District Court, on September 2, 2015. It seems that the in-house lawyer for the entities served subpoenas intends to deliver relevant documents prior to that day.

At least that's what her sworn statements -- before the federal trial court now aver. And I trust she will. She claims the earlier mix-up was plaintiffs' counsel's fault -- that they had served a party (the doctor) who did not control the documents in question. I personally think that's a rather dangerous argument to make, because under applicable federal law, various clinical trial documents, like these -- are to remain (essentially forever) the responsibility of the so-called Principal Investigator under the clinical trial/study. The idea here is that a real person, not a company, hospital or university -- under federal law -- should be signing on for, and responsible for the safe and ethical conduct of the trial. If memory serves, the doctor was the P.I. on those old studies -- some dating back 25 or more years.

In any event, the plaintiffs have now served everyone that might have control of the study documents, and so, their in-house lawyer says the documents will be forthcoming. Here's a bit from her response -- filed today (and the full PDF of it):

. . . .I am Associate University Counsel in the Cornell University Office of University Counsel and counsel for non-party witness Dr. Julianne Imperato-McGinley (“Dr. McGinley”). Dr. McGinley is a full-time member of the faculty of Weill Cornell Medical College ("WCMC"). . . .

[Plaintiffs' counsel] mischaracterizes my communication with him to suggest we have more documents than we do. The available records responsive to the subpoena Plaintiffs served on Dr. McGinley are in the possession, custody and control of WCMC, not Dr. McGinley in her individual capacity. Dr. McGinley, as an individual, has no records in her personal possession that are responsive to the subpoena duces tecum, beyond the information produced. . . .

Most of these records are from 30, 20 and 15 years ago. WCMC reviewed a list of records it had stored, which turned up 16 boxes and potentially more (possibly up to 40) that may include records related to the subject matter of the subpoena. It is important to emphasize that not all of the documents contained in those 16 to 40 boxes are relevant records. The boxes identified in storage were for review to identify the relevant documents. . . .

She goes on to say that at least some will be produced -- but many may not be relevant -- or may be privileged. So. . . I trust that all those following this closely -- you know who you are Messrs. E. & I.(!) -- will enjoy this above bit of federal civil practice "street theater." Now you know. Onward -- and a river runs through it.

Smallish Temodar® Recall -- Cracks In The Childproof Bottle Caps

This is a long standing Schering- Plough/Merck legacy product (now as an authorized generic) -- and the smallish issue has to do with the cap remaining childproof -- not anything to do with purity or safety of the medicine inside the bottle.

Even so, we will note it. Just for a complete record -- from a wire-service press release:

. . . .Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of TEMODAR and Temozolomide capsules (generic) could potentially have cracked caps. . . .

Onward -- some of my Temodar background here -- do use the search box to find more, going back seven years, if you are curious.

Like BMS Before It, Merck Announces A Slowed FDA Timeline In One Anti PD-1 Melanoma Indication, And Acceleration, In Another

About a week ago, BMS announced that its targeted complete response date from FDA had been pushed into November 2015 on an Opdivo® label expansion into other melanoma indications. This morning Merck has done much the same, and this time, in first line melanoma treatments.

Also like BMS, FDA has accepted for priority review Merck's submission in melanoma with differing treatment precursors. Sort of a good news, and delay news -- as a two for one -- echoing BMS of a few weeks past. Here's the bit from StreetInsider:

. . . .The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015. . . .

I might suggest, without looking into it too deeply, that FDA suspects BMS will have better efficacy here in the delayed indication -- thus the November 2015 date for Opdivo, compared to a December date for Keytruda. I'll trust the readership to correct me if I am mistaken about that. Smile. . .

My overall assessment is unchanged. BMS has a clear timing lead. Having said that, the overall market opportunity is so vast, that Merck will generate multiple billions in new reveue here, as well, going into mid-2017 (even as the payers seek limits on price). So, onward -- out into a hot likely rain soaked August workaday world -- but it is teeming with possibilities, as well. . .

Thursday, August 13, 2015

Exclusive -- Propecia® MDL Update: Rule To Show Cause Hearing For Dr. Imperato-McGinley: September 2, 2015

So the worm turns. Apparently, Dr. Imperato McGinley did not turn over the voluminous set of documents associated with her finasteride studies, to the plaintiffs -- as she promised she would. I would not have predicted/expected this outcome. [My May 2015 backgrounder.]

Apparently, she is being -- or has been -- represented by one of the in-house lawyers at the New York Presbyterian/Weill Cornell Medical Center. Also apparently, that in-house counsel has responded that the institution -- not the doctor -- controls custody of the 16 to 40 boxes of clinical trial records thus far pulled from storage. After some wrangling, the in-house counsel has also apparently said that she won't accept service of a subpoena for the boxes, as a representative of either the doctor, or the institution.

And so, a rule to show cause hearing is now set for September 2, 2015 -- in the Eastern District of New York. This will be a hearing as to why the doctor or the institution ought not be held in contempt of court -- for allegedly evading the lawful discovery by subpoena process under the federal rules of civil procedure. I understand that there is a lot to look through, but it will be embarrassing if either of these parties is ultimately held in contempt for failure to go through the boxes, and provide relevant documents. The plaintiffs have even offered to cover the cost of that effort. This ought to be entertaining. From the full pleading (a 6 page PDF file), then -- a bit:

. . . .The only document furnished by Dr. Imperato-McGinley was a two-page “bibliography.” Moreover, Dr. Imperato-McGinley’s responses strongly suggest, consistent with her counsel’s initial representation that there were at least sixteen boxes’ worth of documents, that numerous responsive documents do exist, but Dr. Imperato-McGinley is claiming not to have “possession, custody, or control” of those documents. Indeed, Dr. Imperato-McGinley is careful to assert, in each of her responses, that she has no responsive documents in her “possession”. . . .

Dr. Imperato-McGinley is, according to Merck, one of the most important individuals in the development of Finasteride, and the development of Finasteride in turn appears to be a major component of her life’s work. It is simply implausible – in fact, it is utterly unbelievable –- that Dr. Imperato-McGinley has no “right, authority or practical ability” to obtain and produce the relevant documents within the sixteen to forty boxes’ worth of documents at issue. Indeed, the fact that these boxes were apparently obtained by the attorney who represents her, reviewed with the assistance of a clerk at the undersigned’s expense, and then simply withheld on the eve of the date set for production conclusively demonstrates that numerous responsive documents were and remain within Dr. Imperato-McGinley’s “possession, custody, or control,” or at a bare minimum in the “possession, custody, or control” of her “representatives. . . .”

So, September 2, 2015 should be an interesting morning in the federal courts in Brooklyn. Stay tuned -- off to a charitable board meeting, tonight.

BMO Capital Markets Bumps Merck Target To $70; "Outperform" Rating

Kenilworth saw one major Wall & Broad analyst firm make a material move, north -- in its 12 month price target, this morning.

And the shares are reacting to it, on the NYSE today. $70 is a lofty goal. And we shall -- as ever -- wait to see, here. [Prior background from September 2014 here.] Here's a bit from the street trade press outlets:

. . . ."Although we didn't get the better entry point we were waiting for, we have become more optimistic on Merck's pipeline and believe that the upcoming data readouts should also raise Street expectations and lead to multiple expansion," analyst Alex Arfaei wrote.

Merck's commercial and R&D execution were impressive. The company is expected to have "a good finish" in the back half of the year, Arfaei said, while adding that Merck appeared "on the verge of" five to six years of strong growth, driven by its higher margin specialty franchises, particularly Keytruda and Hep-C. . . .

In the report BMO Capital Markets noted, "After discussions with a number of experts at AAIC, we are more bullish on MK-8931, and now assign ~50% probability of approval in 1Q-2019 with risk-adjusted sales of $4.8B by 2024. We have low expectations for the Anacetrapib REVEAL interim look this year, and estimate 35% probability of success in 2017. . . .

So, a little give and take there, in the finer details -- on Anacetrapib. But as indicated in that last link, that comes as no surprise to us -- so, onward.

Tuesday, August 11, 2015

In The "Caught My Eye" Dept.: $8.2 Billion Written Off; 29,160 Jobs. . . Gone, Since 2010 -- Legacy S-P

This is all as a direct result of the "yard sale" Fred Hassan (and his top six co-horts) made, out of what was legacy Schering-Plough.

Even so, the staggering $8.2 billion above doesn't include the settlement of the various securities class actions that resulted from his mismanagement -- which likely now push the all-in tally close to another $1 billion -- or $9.2 billion, overall. [In addition, there were over 12,000 positions eliminated in the three years before Hassan sold S-P to Merck.] Merck's recently filed SEC Form 10-Q (at pages 5 through 7) discloses what is pretty much the final tally, on the Merck side of the ledger -- of the manifold Hassan & Co.'s miscue costs (per an industry-watching periodical):

. . . .Since 2010, Merck has recorded total pretax accumulated costs of approximately $8.2 billion and eliminated approximately 29,160 positions in connection with the post-Schering-Plough layoffs. . . .

Now you know -- he truly was the "most heartless CEO" in corporate America -- in his day. . . . Onward.

Monday, August 10, 2015

"Son Of Sunscreen Battle Royale" -- Closing Out Legacy Lanham Act/Patent Litigation: Legacy S-P's Sunscreen Brands

Since we have now fully entered the lazy beach-sun drenched vacation days of August, I'll close out the predictions I made in 2012, 2013 and early 2015 -- that the parties would ultimately settle out of court. They have, as of June 15, 2015. So this is mostly about completing the record -- for posterity.

I am quite tardy in posting this, because Merck sold these legacy assets to Bayer, last year. But this is the second large piece of patent infringement/Lanham Act litigation settled on the legacy sunscreen product lines, by Merck as successor to legacy Schering-Plough. Whatever the settlement payments, in either direction, provided for -- the benefit (or payment) almost certainly went to (or came from) Bayer -- since it now holds the brands. Here's a bit of the order of dismissal/settlement:

. . . .Plaintiffs L’Oréal S.A. and L’Oréal USA, Inc. and Defendant MSD Consumer Care, Inc. (collectively the “Parties”) hereby stipulate, pursuant to Federal Rule of Civil Procedure 41(a), and subject to the approval of the Court, to the dismissal of all claims and counterclaims between them in this action with prejudice pursuant to a settlement agreement. Each party shall bear its own costs and attorneys’ fees. The Court shall retain jurisdiction to enforce the settlement agreement reached by the Parties. . . .

Yes. . . it is a slow Merck news day, here. More background, here. A lil' more truthfully, I was just looking for an excuse to re-run that legacy graphic at right. Enjoy your August beach time, one and all -- and stay. . . screened-up!

Sunday, August 9, 2015

Ninth Circuit: Merck Unable To Force Five Non-Consenting CA State Court Plaintiffs Into Federal Court (Yet)

The federal civil procedural nuances are quite complicated here, but what the federal appellate courts sitting in California held, late this past week, is that if a plaintiff alleges injury, and chooses state court as the forum to bring the action, it is not automatically the right of the defendant (Merck) to remove the case to federal court (absent other considerations, like complete diversity of citizenship), and join it to a pending federal MDL. [Last year's backgrounder, here.]

Again, these are still the early stage maneuvers, in the overall incretin mimetic MDL litigation, but these five cases, for now, will not be shoved onto the federal trial court docket in San Diego. Overall, it matters only slightly to Kenilworth, but here is the opinion (as a 31 page PDF file), and the court's reasoning:

. . . ."[T]here is no indication that Congress’s purpose in enacting CAFA was to strip plaintiffs of their ordinary role as masters of their complaint and allow defendants to treat separately filed actions as one action regardless of plaintiffs’ choice." Scimone, 720 F.3d at 885; see Tanoh, 561 F.3d at 953. . . .

"In this case, concluding that plaintiffs’ claims fall outside CAFA’s removal provisions is not absurd, but rather is consistent with. . . the well-established rule that plaintiffs, as masters of their complaint, may choose their forum by selecting state over federal court . . . ."

Incretin mimetics, like Merck's Januvia® (sitagliptin phosphate), are suspected by some medical practitioners and researchers, of being associated with increased risks of pancreatitis -- and perhaps even certain cancer risks. But "suspected" is the key word, there. As of the moment, there appears to be no gold standard, independently rigorous study linking the increased risk of cancer claimed by some, to any incretin mimetic regimen of any particular drug manufacturer. And, while it is true that judicial resources are often well-economized in federal MDL proceedings, there hasn't yet been a binding determination that these cases (over 900 of them, according to page 22 of the just filed SEC Form 10-Q) are appropriately similar -- to allow for an imposed MDL, on all plaintiffs.

All in all, a perfect post-workout Sunday -- so. . . onward we go.

Saturday, August 8, 2015

"Fast Fred" Hassan Joins Amgen Board -- My Condolences, To Amgen Shareholders

I have ignored this tidbit of history (for legacy Schering-Plough folks, at least), long enough.

[Sometimes -- I just need to rant. Forgive me for that. I'll try to be. . . restrained, here.]

At the end of last month, Fast Fred Hassan was added to the board of directors of Amgen -- a fine (and storied) biotech company.

This led some in the MSM to speculate that Amgen may be a target -- given Fred's history.

I will make no comment on that score -- or any other.

All I can offer is. . . my condolences -- to the affected shareholders. Onward, now -- to the northlands!

Friday, August 7, 2015

BMS's Opdivo® Extends Its Immuno-Oncology Lead, In the United Kingdom, Over Keytruda®

Now the U.K.'s NICE need only finally decide the level of reimbursement for NSCLC treatments (not likely to be known until early 2016, officially) -- but as of this moment, BMS will be shipping in regular fashion (not early access/experimental fashion) throughout the UK. Lung cancer is a very high burden disease in England -- and Merck may not come off of experimental "early access" protocols (i.e., low- to no- sales price) there, until late 2015 or early 2016. Thus -- as we've long posited, the BMS lead is stretching to a year or more, in this perhaps $35 billion a year market, by 2018.

From PharmaTimes, then earlier this morning, a bit -- but do go read it all:

. . . .Bristol-Myers Squibb’s Opdivo has launched for lung cancer in the UK, becoming the first immunotherapy available for the disease in the country. The launch follows EU approval for the indication earlier this month. . . .

This may therefore be troubling news to BMS’ main PD-1 rival Merck, whose Keytruda is still only available in the UK for melanoma, and then only through the Early Access to Medicines scheme. . . .

Onward -- and I'm headed to the North Woods this weekend, so blogging may be skittish/interrupted. . .

Thursday, August 6, 2015

Old Simcere (China) JV Returned To JV Partner In Q2 2015: Merck's Just Filed SEC Form 10-Q

This is a rather smallish item, but as I review the SEC Form 10-Q just filed this evening, I thought I'd note it (so I don't forget it!) -- since we've covered the Simcere JV for five years. [Previous backgrounder here. Earlier stuff here.]

The JV will no longer be included in Kenilworth's consolidated results -- and a tiny charge was taken on the divestiture, per page 48 of the SEC filing:

. . . .In March 2015, Merck and Simcere Pharmaceutical Group (“Simcere”) executed a restructuring agreement in which Merck agreed to transfer its 51% ownership interest in the Simcere MSD Shanghai Pharmaceutical Co., Ltd. joint venture to Simcere. As a result, Merck deconsolidated the joint venture and recorded a net loss of $7 million in Other (income) expense, net in the first six months of 2015. . . .

Onward. . . .